Basic Statistics in Laboratory Quality Assurance

– by Sayan Ghoshal
 Learning Objectives on :
Basic Statistics in Laboratory Quality Assurance

• Understand the basic statistical elements of quality

assurance .

• Define & calculate basic statistical terms.

• Application of basic ststics.

 Introduction to Statistics

Statistics is a discipline of
mathemetics that involves the
collection, organization, analysis,
interpretation, and presentation
of data.
 Usage of Statistics in
Laboratory Quality Assurance

Statistical methods are used to

document, monitor & evaluate the
data generated by lab processes that
directly or indirectly affects patient
results. For example :
• In Pre-Analytical Stage : Sample
shipment temperature data logger,
Number of hemolysed samples in a
particular time-frame etc.
 Usage of Statistics in
Laboratory Quality Assurance

• In Analytical Stage : Statistical

Analysis of Instrument
performance by IQC data,
Statistical Interpretation of
Proficiency Testing, Method
Verification of new instrument
etc.
 Usage of Statistics in
Laboratory Quality Assurance

• In Post Analytical Stage : Statistical

Analysis of the number of
Ammended Report, Typing Errors,
etc.
 Calculation & Use of Statistics
in Analytical Stage
• QC statistics for each test performed in the
laboratory are calculated from the QC data
collected by regular testing of control products.
The data collected is specific for each level and lot
number of control.
• Consequently, the statistics and ranges calculated
from this data are also specific for each level and
lot number of control and reflect the behavior of
the test at specific concentrations.
• The most fundamental statistics used by the
laboratory are the mean [x¯ ] and standard
deviation [s].
 Calculation Of Mean

• The mean (or average) is the laboratory’s best

estimate of the analyte’s true value for a specific
level of control.
• To calculate a mean for a specific level of control,
first, add all the values collected for that control.
Then divide the sum of these values by the total
number of values.
• For instance, to calculate the mean for the data
{4.0, 4.1, 4.0, 4.2, 4.1, 4.1, 4.2}. The sum [ ∑] is
28.7. The number of values is 7 (n = 7). Therefore,
the mean is 4.1 (or 28.7 divided by 7).
 Calculation Of
Standard Deviation
• Standard deviation is a statistic that quantifies
how close numerical values (i.e., QC values) are in
relation to each other with respect to the
arithmetic mean.
• Standard deviation as a word can be abbreviated
as SD. Standard deviation is calculated for control
products from the same data used to calculate
the mean. It provides the laboratory an estimate
of test consistency at specific concentrations. The
repeatability of a test may be consistent (low
standard deviation, low imprecision) or
inconsistent (high standard deviation, high
imprecision).
 Precision & Accuracy

• Accuracy and precision are

both ways to measure
results.
• Accuracy measures how
close results are to the true
or known value.
• Precision, on the other hand,
measures how close results
are to one another.
Accuracy & Precision
 Coefficient Of Variation
The Coefficient of Variation [CV] is the ratio of
the standard deviation to the mean and is
expressed as a percentage.The CV allows the
laboratory professional to make easier
comparisons of the overall precision. Since
standard deviation
typically increases as the concentration of the
analyte increases, the CV can be regarded as a
statistical equalizer. If the laboratory is
comparing precision for two different
methods/assays and uses only standard
deviation, he or she can be easily misled.
 LJ Charts and Statistical Rules
Creating a Levey-Jennings Chart :
Standard deviation is commonly used for preparing Levey-Jennings (L-J or LJ)
charts. The Levey-Jennings chart is used to graph successive (run-to-run or
day-to-day) quality control values. A chart is created for each test and level of
control. The first step is to calculate decision limits.
These limits are 1 standard deviation (±1s) , 2 standard deviations (±2s) and 3
standard deviations (±3s) from the mean.
 LJ Charts and Statistical Rules
Levey-Jennings Chart :
 LJ Charts and Statistical Rules
Statistical Rules :

Quality control rules can be expressed as NL where N represents the

number of control observations to be evaluated and L represents the
statistical limit for evaluating the control observations.
Thus 1-3s for example represents a control rule that is violated when
one control observation exceeds the ±3s control limits.8
The specific QC rule (or rules) to be used for a test method is selected
based on the performance of the test method with respect to its quality
specification.
 LJ Charts and Statistical Rules

Rule 1-2s
This is a warning rule that is violated
when a single control observation
is outside the ±2s limits.
 LJ Charts and Statistical Rules

Rule 1-3s
This rule identifies unacceptable
random error or possibly the
beginning
of a large systematic error. Any QC
result
outside ±3s violates this rule and
should
be rejected.
 LJ Charts and Statistical Rules

This rule identifies systematic error

only.
The criteria for violation of this
rule are:
■ Two consecutive QC results
■ Greater than 2s
■ On the same side of the mean
There are two applications to this
rule: within-run and across-runs.
 LJ Charts and Statistical Rules

R4s Rule :
This rule identifies random error
only and
is applied only within the current
run.
If there is at least a 4s difference
between
control values within a single run,
the rule
is violated for random error.
 LJ Charts and Statistical Rules

Rule 10x :
These rules are violated when there are:
■ 10 control results
■ On the same side of the mean regardless of the specific standard
deviation in which they are located. Each of these rules also has two
applications:
■ Within control material (e.g., all level 1 control results) or across control
materials (e.g., Llevel 1, 2, and 3 control results in combination).
■ Within control material violations indicate systematic bias in a single
area of the method curve while violation
of the across control materials application indicates systematic bias over a
broader concentration.
LJ Charts and Statistical Rules
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